FLUORETS STERILE OPHTH. STRIPS
FDA 510(k) clearance K831621 · decided 1983-07-18
Clearance details
- K-number
- K831621
- Device name
- FLUORETS STERILE OPHTH. STRIPS
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-19
- Decision date
- 1983-07-18
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- KYC
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BARNES-HIND ROSE BENGAL OPHTHALMIC STR. (K810285) | Barnes-Hind, Inc. | 1981-04-17 |
| FLUORESOFT (K780125) | Holles Laboratories, Inc. | 1978-03-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
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| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |